Body fluid flow control device

ABSTRACT

A device to provide body fluid flow control in the form of a valve to be located within a duct or passageway. The device is controlled through pressure above a preselected threshold. Bulk resilience about a passageway in a valve body provides the mechanism for controlled flow. One-way valve operation may be provided through a flap or through a pressure differential on the valve body depending upon the direction of flow. A frame structure positioned within a resilient seal includes longitudinally elongate elements which may be of spring material, malleable material or heat recoverable material so as to accomplish an initial insertion state and an expanded anchoring state. A valve support transitions between the resilient seal portion and the valve body to insure that the states do not change the threshold opening pressure. Insertion devices may be employed to position and actuate a change of state of the frame in the body duct or passageway.

[0001] This is a continuing application of U.S. patent application Ser.No. 09/397,218, filed Sep. 16, 1999, which is a continuing applicationof U.S. patent application Ser. No. 08/931,552, filed Sep. 6, 1997, andissued as U.S. Pat. No. 5,954,766, which disclosures of the above areincorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] The field of the present invention is valve mechanisms for use inthe human body.

[0003] Valves play an important role in a number of bodily functions.One such physiologic valve is in the urinary tract. Valve failure inthis system leads to urinary incontinence, a significant health issue.Urinary incontinence is estimated to affect some ten million Americans.The full extent of this problem is unknown because less than half ofaffected adults are believed to actually seek medical attention.

[0004] Devices are available to assist in the control of urinaryincontinence. Such devices include external valves, valves extendingthroughout the lower urinary tract and into the bladder, devicesextending through long portions of the urethra and implanted prothesesas well as injected bulking agents which support the urethral sphincterto enhance operation. Such devices are often inconvenient, uncomfortableand/or require surgical insertion. Other devices are considered overlyintrusive.

[0005] Native valves are also found in cardiovascular systems. In veins,native venous valves promote one-way flow toward the heart from theperiphery. Diseases exist such as venous thrombosis and thrombophlebitiswhich can render native venous valves incompetent, resulting in edema.Replacement of these artificial valves with artificial ones couldprovide substantial health benefits.

[0006] The pulmonic valve associated with the heart is yet anothernative flow control mechanism which can exhibit incompetence eithercongenitally, through disease or iatrogenically due to treatment ofpulmonary stenosis. A one-way valve positioned distal to the nativepulmonic valve within the pulmonary artery could be of substantialbenefit in overcoming this problem.

SUMMARY OF THE INVENTION

[0007] The present invention is directed to a body fluid flow controldevice which includes an ability to seal about the device in the fluidpassageway, a placement and retention format for the device and a valvebody capable of either or both a pressure threshold for operation and aone-way flow restriction. The valve body preferably end bulk resilienceand a passage therethrough which is closed by that bulk resilience. Thismay be defined by an elastomeric or other polymeric body with a passagetherethrough cut without the removal of material. A single slit, a crossor a star shaped cut are included among the possibilities. One-way flowmay be accomplished through a flap or other inhibitor physicallyimpeding flow in one direction or by a configuration of the valve toemploy passage pressure to prevent opening.

[0008] In a separate aspect of the present invention, such devices ascontemplated above are combined with mechanisms to assist intransforming the state of the device from insertion to anchoring.

[0009] Accordingly, it is a principal object of the present invention toprovide a flow control device for the human body such as for urinary,venous or pulmonic placement. Other and further objects and advantagesmay appear hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010]FIG. 1 is a perspective view of a first flow control device.

[0011]FIG. 2 is a cross-sectional side view of the device of FIG. 1.

[0012]FIG. 3 is a cross-sectional side view of a second flow controldevice.

[0013]FIG. 4 is an end view of a third fluid flow control device.

[0014]FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. 4.

[0015]FIG. 6 is an end view of yet another fluid flow control device.

[0016]FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. 6.

[0017]FIG. 8 is a cross-sectional view of yet another fluid flow controldevice.

[0018]FIG. 9 is a cross-sectional view of yet another fluid flow controldevice.

[0019]FIG. 10 is a cross-sectional view of yet another fluid flowcontrol device.

[0020]FIG. 11 is a cross-sectional view of the device of FIG. 10 with aballoon expander positioned within the device.

[0021]FIG. 12 is a cross-sectional side view of an insertion tool with afluid flow control device in place.

[0022]FIG. 13 is a prospective view of another frame.

[0023]FIG. 14 is a prospective view of yet another frame.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024]FIGS. 1 and 2 illustrate a first fluid flow control device capableof one-way flow, the sealing of a body passageway and pressureactuation. The device includes a resilient seal 20 which, in this firstembodiment, includes a cylindrical elastomeric or, more generically,polymeric material capable of sealing within the interior of a body ductor passageway. This resilient seal is shown in this embodiment to becylindrical but may be tapered through a portion thereof. In eitherinstance, the seal has a substantially circular cross section to fitwithin the body duct or passageway.

[0025] To one end of the seal 20, a valve support 22 extends inwardlyfrom an attachment to the valve body. This valve support 22 preferablyprovides a barrier to flow through the resilient seal. The support 22 isconveniently formed as one piece with the seal 20.

[0026] A valve body 24 is attached to the valve support 22 about theouter periphery of the body 24. The valve body 24 is also of polymericmaterial and may be most conveniently formed as one piece with the seal20 and the valve support 22. The body 24 is shown in this firstembodiment to define a passage 26 which is shown to be a single slit.The slit 26 extends longitudinally through the valve body. The body ofthe valve being polymeric and resilient is able to provide bulkresilience to maintain its natural state. As the slit 26 is preferablymanufactured without removal of material from the valve body 24, theresilience of the body closes the slit 26 so that no flow can occur.Through empirical testing, an appropriate size of the slit 26 andoverall body size and shape of the valve body 24 will define a thresholdpressure which may be applied to one end of the valve to cause the slit26 to open. For purposes of urinary tract control, this opening pressureshould be in the range of about 0.2 psi to 3.0 psi. For intervascularplacement, the threshold should be from about 0.005 psi to 1.0 psi.

[0027] The valve body 24 acts in this embodiment as a one-way valvebecause of the substantially parallel sides to either side of the slit26. In the event that flow builds up on the side of the valve with theextending substantially parallel sides 28, the pressure will not onlybuild up at the slit 26, it will also build up on the parallel sides 28as well. The pressure on the sides will prevent the slit from opening.

[0028] A frame, generally designated 30, is located within theperipheral resilient seal 20. This frame 30 is contemplated to be ametallic member having an expanded metal cylinder 32 defined bylongitudinally extending elements 34. In this instance, thelongitudinally extending elements 34 are interconnected as oneconstruction so as to form the expanded metal cylinder.

[0029] The resilient seal forming the peripheral element about the frame30 to define a seal with the duct or passageway in which the device isplaced may be affixed to the frame 30 by any number of conventionalmeans. For example, the frame 30 may be bonded to the resilient seal 20.The resilient seal 20 may be formed through injection molding, blowmolding, insertion molding or the like with the frame in place withinthe mold such that the frame 30 becomes embedded within the seal 20.There may be a physical interlocking through the use of an inwardlyextending flange on the open end of the resilient seal 20 to physicallyretain the frame 30.

[0030] The frame 30, being of expanded metal, is capable of being easilystretched to expand from a stable first state to a stable expandedstate. The first state, referred to as the insertion state, iscontemplated with the overall diameter of the frame 30 and thesurrounding resilient seal 20 exhibiting a first diameter. With theframe 30 expanded to what may be termed an anchor state, the resilientseal 20 also expands. In the expanded state, the overall device isintended to fit with interference in the duct or passage. Beforeexpansion, easy insertion is contemplated with clearance.

[0031] The construction of this first embodiment provides for the valvesupport 22 to extend longitudinally in a cylindrical element 36 from aninwardly extending disk element 38. A further inwardly extending diskelement 40 extends to the valve body 24. The employment of thecylindrical element 36 between these disk elements 38 and 40 is intendedto isolate the valve body 24 from the displacement of the resilient seal20 as the frame is expanded from an insertion state to an anchor state.Distortion of the valve which may result in a change in the thresholdpressure to open the valve may be avoided.

[0032] Looking to FIG. 3, a similar view to that of FIG. 2 illustrates asecond embodiment. This embodiment differs from the prior embodiment inthe redirection of the valve body 24 at the disk 40. With thatredirection, the valve body 24 is positioned to face in the oppositedirection. In this way, the one-way feature operates to provide flow inthe opposite direction relative to the frame 30 and resilient seal 20.

[0033] Turning to FIGS. 4 and 5, another embodiment is illustrated.Identical reference numbers are applied to those of the first embodimentto similar structures and functional elements. Presenting a morequantitative description, the wall thickness of the elastomeric polymerdefining the resilient seal 20, valve support 22 and valve body 24 iscontemplated to be between approximately 0.005″ and 0.050″. The width ofthe slit is approximately 0.024″ while the outside diameter of theresilient seal 20 is approximately 0.349″. The length of this element iscontemplated to be approximately 0.60″. The frame is cylindrical with anOD in the insertion state of approximately 0.329″, a length ofapproximately 0.304″ and a thickness of approximately 0.005″ to 0.015″.This member is preferably of stainless steel or nitinol. The metallicmember in this and each other embodiment is contemplated to besubstantially nonreactive with body fluids and the body itself or coatedwith such a nonreactive material. Other dimensions can also bemanufactured depending on the size of the placement.

[0034] Turning to the embodiment of FIGS. 6 and 7, substantially thesame device is illustrated as in the prior embodiment. Again, thecorrespondence of reference numerals reflect similar structures andfunctional features. This device has an added flap 42 overlying thepassage 26. The flap 42 is attached by adhesive, bonding or otherconventional procedure. The passage 26 may again be a slit as previouslydescribed so as to provide a threshold pressure level before opening. Ifa passageway is presented instead, the device will simply act as aone-way valve.

[0035] Turning to FIG. 8, a different overall exterior configuration ispresented as well as a different frame. A polymeric resilient seal 44 isshown to extend over a frame, generally designated 46. The frame 46includes longitudinally extending elements 48. The elements 48 extendfrom a conically shaped portion 50 of the frame 46. This conicallyshaped portion 50 is truncated to provide a wide passageway 52 foroperation of the valving mechanism. The resilient seal 44 forms a skirtwhich extends inwardly to a valve support 54 which is located about thetruncated conical portion 50. The valve support 54 and the resilientseal 44 are preferably of the same piece of material. A valve body 56extends across the passageway 52 in an appropriate thickness to providethe appropriate bulk resilience to accommodate a threshold openingpressure. A passage 58, shown here to be a slit extends through thevalve body 56.

[0036] Turning to FIG. 9, a device similar to that of FIG .8 isdisclosed. Common reference numerals indicate similar elements andfunctional features. The resilient seal 44 extends over thelongitudinally extending elements as a skirt with the ends of theelements 48 extending outwardly therefrom. A truncated somewhat conicalportion 50 actually forming a dome shape extends to a passageway 52. Thevalve support 54 covers this portion 50. A truncated cone shaped element60 forms a further part of the valve. It may be part of the same pieceof material as the resilient seal 44 and valve support 54. A valve body62 is shown to be a cylindrical element with a passage 58, shown here tobe slits in the form of a cross or star extending longitudinallytherethrough.

[0037] The length of the valve body 62 establishes that the passage 64will operate only in expansion and not through bending of thecomponents. Thus, a substantially greater threshold level of pressure isanticipated for this configuration.

[0038]FIG. 10 illustrates yet another fluid flow control device. Thisdevice includes a resilient seal 66 in the form of a cuff extendingabout one end of the periphery of the device. The frame 68 is generallyon the outside of the valve with longitudinally extending elements 70extending into the cuff 66. The valve support 72 extends within theframe 68 to a valve body 74 which forms a disk element with a slit 78therethrough. The frame 68 includes a section in the form of a soliddisk 80 with a passageway 82 therethrough. The passageway 82 issubstantially larger than the slit 78 in order that it not interferewith the operation thereof. The solid disk 80 also acts to tie togetherthe longitudinally extending element 70 extending out to the cuff 66.

[0039] A variety of slits or other mechanisms may be employed to achieveflow through a passage above a preestablished threshold pressure. Withthin membranes, a slit or multiple crossed slits can employ a bendingcomponent to achieve flow. The bulk resilience is employed more inbending than in radial compression away from the cut or cuts. Withlonger passageways, radial compression outwardly from the passageprovides the controlling mechanism. The thickness of the resilient sealas measured laterally of the slit can be of importance in one-way flowoperation. With a thin lateral wall thickness, the pressure surroundingthe valve can prevent its opening. Thus, flow would only occur from theside of the valve where pressure cannot accumulate and prevent itsopening.

[0040] The frame is to be capable of two states, an insertion state andan anchoring state. The anchoring state is larger than the insertionstate by the laterally extending resilient elements being outwardly ofthe insertion position of these elements when they are in the anchorstate.

[0041] To achieve these two states, a number of mechanisms may beemployed. First, a malleable material can be used. Because thepassageways and ducts within the body are quite resilient, large changesin diameter are not required. Consequently, almost any metal is capableof sufficient malleability, particularly if it is employed in anexpanded metal state, for example. Reference is made to the embodimentof FIGS. 1 and 2. The choice of metals can become more dependent uponsatisfying environmental needs within the body.

[0042] Another mechanism which may be employed to accommodate thistwo-state requirement is spring resilience. The insertion state can beachieved through a preconstraint of the longitudinally extendingelements within the elastic range of these elements. Once positioned,the elements can be released to expand into an anchoring state.Constraining tubes or pull wires may achieve the initial insertionstate.

[0043] Another mechanism which may be used to accomplish both theinsertion and the anchor states of the frame is the heat recovery ofmaterials available with alloys such as certain nickel titanium alloys.Preferably the transition temperature of such devices is below bodytemperature. Under these circumstances, a cool device can be positionedand allowed to attain ambient temperature. The unrecovered state of theframe would be in the insertion position with the longitudinallyextending Another use of this material may be through a heating of thedevice above body temperature with a recovery temperature zone abovethat of normal body temperature but below a temperature which may causeburning. The device might be heated electrically or through themodulation of a field.

[0044] To accomplish a transition from the insertion state to theanchoring state, a variety of devices may be employed. An elongateexpander is illustrated in FIG. 11. A balloon 84 is presented at the endof an elongate passage 86 through which pressure may be transmitted. Thefluid flow control device can be inserted on the mechanism making up thepassage 86 and balloon 84. When in position, the balloon 84 is expandedthrough the application of pressure to the accessible end of the passage86. The malleable longitudinally extending elements are bent beyondtheir yield point into an interfering engagement with the wall of thepassageway in the body.

[0045] Another mechanism for providing an elongate expander andinsertion tool is illustrated in FIG. 12. The device includes an outersheath 88 into which is positioned a fluid flow control device which haslongitudinally extending elements that are of spring material. Theelements are bent such that the frame is radially constricted. The sizeof the sheath inner diameter is such that the spring elements are notbent to the point that they exceed the elastic limit. A ram 90 extendsinto the sheath 88 to force the fluid flow control device from the endof the sheath. As the device is released from the sheath 88, it willnaturally expand to the anchored state. This same mechanism may beemployed with any of the devices for placement regardless of whether themechanism for expansion is deformation, heat recovery or resilience.Naturally, the ram 90 can accommodate a heating element or balloonmechanism depending upon the appropriate need.

[0046] Finally, FIGS. 13 and 14 illustrate two additional forms of theframe which may be employed in place of one of the other framesdisclosed. The frame may form a complete cylinder or a rolled sheet 92as in FIG. 13. A frame which is another alternative is seen in FIG. 14.A longitudinally extending element 94 is formed into a coil. Thesedevices may be of heat recoverable material so as to form an insertionstate and an anchor state or be of spring material constrained to areduced diameter for insertion.

[0047] Considering the use of these devices, the thresholds are selectedwith the appropriate pressures in mind. With incontinence, the thresholdpressure is high enough to prevent leakage as normal pressure builds inthe bladder. When the bladder is to be voided, abdominal pressure isused. The threshold pressure is also low enough that the abdominalpressure will overcome the resistance and allow flow. Where placement isin the cardiovascular system, minimum resistance to flow in onedirection may designed into the valve. In this application, however,substantial resistance to flow is designed into the valve to eliminateflow in one direction for all pressures contemplated.

[0048] Accordingly, a number of improved devices for providing bodyfluid flow control are disclosed. While embodiments and applications ofthis invention have been shown and described, it would be apparent tothose skilled in the art that many more modifications are possiblewithout departing from the inventive concepts herein. The invention,therefore is not to be restricted except in the spirit of the appendedclaims.

What is claimed is:
 1. A body fluid flow control device comprising aresilient seal of substantially annular configuration; a frame extendingwithin at least a portion of the resilient seal and including apassageway extending longitudinally through the frame and at least onelongitudinally extending element having an insertion state and ananchoring state, the anchoring state being with the at least onelongitudinally extending element outwardly of the insertion state,thereby expanding the portion of the resilient seal within which theframe extends, the passageway being inwardly of the at least onelongitudinally extending element; a valve body having bulk resilienceand a passage therethrough resiliently biased closed by the bulkresilience and communicating with the passageway; a valve support aboutthe valve body and attached to the valve body and to the resilient seal,the passage being in communication with the passageway extendinglongitudinally through the frame.
 2. The body fluid flow control deviceof claim 1, the resilient seal further including a skirt extending atleast partially over the at least one longitudinally extending elementto form a peripheral seal.
 3. The body fluid flow control device ofclaim 1, the resilient seal further including a skirt extending withinthe at least one longitudinally extending element and having a cuff overone end of each of the at least one longitudinally extending element toform a peripheral seal.
 4. The body fluid flow control device of claim1, the resilient seal further including a skirt extending fully over theframe.
 5. The body fluid flow control device of claim 1, the passagehaving a predetermined fluid opening pressure.
 6. The body fluid flowcontrol device of claim 5, the fluid opening pressure being about 0.2psi to 3.0 psi for urinary incontinence.
 7. The body fluid flow controldevice of claim 5, the fluid opening pressure being about 0.005 psi to1.0 psi for intervascular placement.
 8. The body fluid flow controldevice of claim 1, the passage being a single slit.
 9. The body fluidflow control device of claim 1, the resilient seal, the valve body andthe valve support being one piece.
 10. The body fluid flow controldevice of claim 1, the at least one longitudinally extending elementbeing heat recoverable with a transition temperature range below areasonable range of human body temperatures.
 11. The body fluid flowcontrol device of claim 1, the at least one longitudinally extendingelement being spring biased toward the anchoring state and being held inthe insertion state by a release wire separable from the frame.
 12. Thebody fluid flow control device of claim 1 further comprising a flapattached to the valve body adjacent the passage and extending over thepassage to restrict flow to one direction through the passage.
 13. Thebody fluid flow control device of claim 1 further comprising an elongateexpander means for expanding the at least one longitudinally extendingelement from the insertion state to the anchoring state, the at leastone longitudinally extending element defining a concavity receiving atleast a portion of the elongate expander means.
 14. The body fluid flowcontrol device of claim 13, the elongate expander means including aballoon at a distal end thereof with a passage extending substantiallythe length of the elongate expander means.
 15. The body fluid flowcontrol device of claim 13, the elongate expander means including anouter sheath into which the resilient seal and the frame arepositionable in the insertion state and a ram extending within thesheath to engage the frame in the passageway extending longitudinallythrough the frame.